Point-Of-Care TBI Detection System For Head Injured Patients In The Emergency Department (READ-TBI)

April 18, 2016 updated by: BrainScope Company, Inc.

Use Of A Point-Of-Care TBI Detection System For Identification Of Head Injured Patients Who Present To The Emergency Department

A prospective, non-randomized trial for the extension and replication of the development database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to test the clinical utility of the BrainScope technology for the acute identification of traumatic structural brain injury in the TBI population, following closed head injury. The data generated will serve to validate and/or refine the current algorithms to detect acute, traumatic, structural brain injury.

Study Type

Observational

Enrollment (Actual)

421

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University- Grady Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • R Cowley Shock Trauma Hospital
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Wayne State University - Sinai Grace Hospital
      • Detroit, Michigan, United States, 48235
        • Wayne State University - Detroit Receiving Hospital
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University - Barnes Jewish Hospital
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Houston, Texas, United States, 77030
        • UT-Houston Health Science Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are suspected of a traumatic, closed head injury within 24 hours will be recruited from patients who enter the Emergency Department at hospitals that are participating as clinical sites for this study.

Description

Inclusion Criteria:

  • Subjects who are admitted to the ED and are suspected of a traumatic, closed head injury within 24 hours. The patient will have a GCS 12-15 upon arrival to the ED even if GCS was lower prior to arrival to the ED (e.g., at the time of injury).

Exclusion Criteria:

  • Subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin.

  • In addition,

    • subjects with dementia,
    • Parkinson's Disease,
    • multiple sclerosis,
    • seizure disorder,
    • brain tumors,
    • history of brain surgery,
    • psychiatric disorder being managed by a psychiatric healthcare professional/provider,
    • substance dependence,
    • history of TIA or stroke within the last year,
    • currently receiving dialysis or in end-stage renal disease,
    • active fever defined as greater than 100 degrees F or 37.7 degrees C,
    • current condition is "critical" in the opinion of the investigator,
    • subject is suffering from an open head injury,
    • subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications.
  • Subjects below the age of 18 years, and prisoners will not be eligible for study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Extend and replicate a database of brain electrical activity and clinical information collected from patients who present to the ED following closed head injury
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrainScope Company, Inc.

Investigators

  • Principal Investigator: Douglas C Oberly, BrainScope Company, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-Ahead

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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